Kool Kit® Neonate

Basic Information

• Brand Name: Kool Kit® Neonate
• Primary DI: 20613031829508
• Version / Model: 950
• Catalog Number: 82950
• Company Name: Gentherm Medical, LLC
• Labeler DUNS: 004249462
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2017-08-30
• Public Version: 4
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: 34e49287-1864-45bf-b237-d3c4ada4f27b

Device Description

Thermal Regulating System

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DWJ	System, Thermal Regulating	Cardiovascular	870.5900	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61251	External circulating-fluid core temperature regulation system pad, single-use	An underlay, overlay, or wrap(s) through which temperature-regulated fluid is circulated, as part of an external circulating-fluid core temperature regulation system, intended to elevate and/or lower a patient’s core body temperature, typically in the operating room (OR), intensive care unit (ICU), or a recovery unit. The underlay/overlay is available in a variety of lengths, widths, and thicknesses to accommodate body size and application (e.g., adult/paediatric, full-/partial-body). It is intended to be used by a healthcare professional in a clinical setting. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20613031829508	GS1
Unit of Use	10613031829501	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Depth	1.63	Inch
Width	11.0	Inch
Length	14.25	Inch
Weight	0.15	Pound

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 150 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: -40 – 65.6 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 20 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 59 – 86 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 20 – 95 Percent (%) Relative Humidity